Estar-ZE
FDA 510(k) K242521 · Osstem Implant Co., Ltd.
510(k) numberK242521
Submission
- Device name
- Estar-ZE
- Applicant
- Osstem Implant Co., Ltd.
Siheung-Si, KR - Received
- August 23, 2024
- Decision date
- November 20, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K261046 | Dental Zirconia Blank & Coloring LiquidEIH · Traditional | Hunan Qinghao Puzhong Technology Co., Ltd. | 07/17/2026SE |
| K262195 | Dandy Ceramic Stain and GlazeEIH · Traditional | Zima International Inc., dba Dandy | 06/30/2026SE |
| K260918 | Zolid LunarisEIH · Traditional | Amann Girrbach AG | 06/29/2026SE |
| K260859 | Rosetta SM, Rosetta SPEIH · Traditional | Hass Corp. | 06/11/2026SE |
| K253191 | DCMhotbond zirconEIH · Traditional | Dental Creativ Management GmbH | 05/21/2026SE |
| K260067 | Eternal Art Porcelain PowdersEIH · Traditional | Shandong Huge Dental Material Corporation | 04/09/2026SE |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankEIH · Traditional | Bloomden Bioceramics (HuNan) Co., Ltd. | 03/30/2026SE |
| K253953 | IPS e.max ZirconiaEIH · Traditional | Ivoclar Vivadent, Inc. | 03/10/2026SE |
More from Ivoclar Vivadent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251434 | Healing Abutment SystemNHA · Traditional | 03/04/2026SE |
| K251569 | Bone ScrewDZL · Traditional | 08/13/2025SE |
| K233806 | T2 PlusOAS · Traditional | 09/06/2024SE |
| K233194 | TS Abutment SystemNHA · Traditional | 02/20/2024SE |
| K232220 | SS Abutment SystemNHA · Traditional | 12/05/2023SE |
| K232012 | N1EHD · Traditional | 11/28/2023SE |
| K222778 | Osstem Implant SystemDZE · Traditional | 09/23/2023SE |
| K221684 | Osstem Abutment SystemNHA · Traditional | 09/08/2022SE |
| K212303 | T2OAS · Traditional | 09/21/2021SE |
| K210097 | Estar-ZEIH · Traditional | 07/02/2021SE |
Questions and answers
When was Estar-ZE cleared by the FDA?
Estar-ZE (K242521) received a 510(k) decision of Substantially Equivalent on November 20, 2024, 89 days after the submission was received.
What is the product code of K242521?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.